About Covid-19
Veru drug trial stopped early for 'overwhelming efficacy' in seriously ill COVID-19 patients “Veru said Monday that its cytoskeleton disruptor sabizabulin reduced deaths by 55% compared to placebo in a Phase III trial of seriously ill patients hospitalised for COVID-19. CEO Mitchell Steiner said the study is the first to demonstrate a clinically and statistically meaningful survival benefit in this population, adding ‘we strongly believe that sabizabulin, with its dual anti-viral and anti-inflammatory properties…can be that greatly needed oral therapy for hospitalised moderate-to-severe COVID-19 patients.’
Veru said the study was stopped early on the advice of an independent data monitoring committee due to ‘overwhelming’ efficacy, with company shares surging over 203% on the news.”
Many Republicans are ready to end the public health emergency “The Biden administration is widely expected to renew the declaration expiring at the end of the week, ensuring the continuation of critical resources to battle the coronavirus pandemic. But the decision comes amid increasing pressure from Republicans to wind down such supports and to treat the virus as endemic…
Here’s a snapshot of what could go away without a public health emergency:
Private insurers and Medicare would no longer cover free, rapid at-home tests.
Telehealth services wouldn’t be available to millions of Medicare beneficiaries roughly five months after the emergency ends.
States would begin the lengthy process of determining who no longer qualifies for Medicaid and must be removed from the safety-net program.”
If the PHE is extended before April 16, it would expire July 15.
Moderna Recalls Nearly 800,000 Doses of Its COVID-19 Vaccine “Moderna has recalled 764,900 doses of its COVID-19 vaccine, Spikevax, due to potential contamination with a foreign body.
The affected lot was manufactured by ROVI Pharma Industrial Services at a contract manufacturing facility in Spain.”
The recall apparently does not affect doses in the US.
FDA Updates EUA for J&J COVID-19 Vaccine to Extend Shelf Life “The FDA has amended its Emergency Use Authorization (EUA) for Johnson & Johnson’s COVID-19 vaccine, extending the vaccine’s shelf life from nine months to 11 months, provided the doses are stored between 2 and 8 degrees Celsius (between 35.6 and 46.4 Fahrenheit).”
About hospitals and healthcare systems
HHS will consider medical debt practices when making grant decisions “Service providers may be asked to provide information about their medical bill collection practices, patient litigation, financial aid, financial product offerings, and practices for contracting with third parties or foreclosing debts.
HHS will use this information to make grant decisions. The department will also make some data public and report potential violations to law enforcement.”
This measure is part of this announcement: Harris says White House will seek to ease Americans' medical debt burden Much else in the press release has been previously discussed, like The No Surprises Act.
FAIR SHARE SPENDING, How much are hospitals giving back to their communities? From the Lown Institute: “The Institute calculated “fair share spending” for more than 1800 hospitals across 275 nonprofit hospital systems by comparing each system’s spending on charity care and community investment to the value of its tax exemption…
KEY TAKEAWAYS
Out of 275 nonprofit hospital systems evaluated, 227 spent less on charity care and community investment than the estimated value of their tax breaks — what we call a “fair share deficit.”
The total fair share deficit for these 227 hospital systems amounted to $18.4 billion in 2019.
The ten systems with the largest deficits account for $5.6 billion (30%) of the total fair share deficit. Many of these systems also received hundreds of millions from the CARES Act in 2020 and ended the year with high net incomes.
In seven states, the total fair share deficit for all hospitals exceeded $1 billion (CA, PA, NY, OH, IL, MI, MA).”
Read the report for hospital and state-level details.
United States Files Suit Against Methodist Le Bonheur Healthcare And Methodist Healthcare-Memphis Hospitals “The United States today filed a complaint in intervention alleging violations of the False Claims Act (FCA) and the Anti-Kickback Statute (AKS) by Methodist Le Bonheur Healthcare (MLH) and Methodist Healthcare Memphis Hospitals (collectively, Methodist), for paying unlawful kickbacks to West Clinic, P.C. (West) in exchange for West’s patient referrals, announced U.S. Attorney Mark H. Wildasin for the Middle District of Tennessee.”
Read this Justice Department press release. The damages for Medicare and Medicaid are claimed to be more than $800M!
About pharma
The top 20 pharma companies by 2021 revenue “Of the world’s top 20 pharmas ranked by 2021 revenues, 12 had at least 10% growth, including five that saw their sales boom at least 40%.
No company pulled in more revenue from COVID products than Pfizer. Fueled by Comirnaty, Pfizer nearly doubled its top line.
Johnson & Johnson needed a healthy 14% increase in revenue to stay comfortably in front of Pfizer and remain in the top spot, where it has resided since 2012. But that reign is in jeopardy this year, as Pfizer is projecting combined sales of $54 billion from Comirnaty and its oral COVID-19 treatment, Paxlovid.”
See the article for the full list.
US jury sides with Seagen in Enhertu patent case against Daiichi Sankyo “Seagen announced Friday that it has been awarded close to $42 million in a lawsuit against Daichi Sankyo involving the breast cancer treatment Enhertu (trastuzumab deruxtecan). A federal jury for the Eastern District of Texas found that Daiichi Sankyo, which is partnered on the antibody-drug conjugate (ADC) with AstraZeneca, infringed Seagen's patent on technology that delivers chemotherapy drugs directly to cancer cells. Jurors also rejected arguments that the patent is invalid because it does not cover a novel invention.”
Walgreens and Other Companies Headed to Opioid Trial “A federal judge has given the go-ahead for the San Francisco county and city to take Walgreens and several pharmaceutical companies to trial on April 25 for alleged violations relating to the sale and distribution of opioids…
In the complaint, filed in December 2018, San Francisco charged the defendants with false advertising, negligence, negligent misrepresentation and fraudulent concealment, among other alleged violations.”
Pfizer announces acquisition of Australian digital health company “Pfizer has announced it will acquire ResApp Health (ASX:RAP) in an acquisition that values the Australian digital health company at $100 million.
ResApp has developed smartphone applications that support the diagnosis and management of respiratory disease.
Its machine learning algorithms use sound to diagnose and measure the severity of respiratory conditions without the need for additional accessories or hardware.
Its ResAppDx is an approved smartphone-based acute respiratory disease diagnostic test for use in telehealth, emergency department and primary care settings. Its SleepCheck smartphone application allows consumers to self-assess their risk of sleep apnoea.”
CVS settles with Justice Department to make vaccine scheduling more accessible “CVS has agreed to make its COVID-19 vaccine registration website accessible for people with disabilities as part of a settlement with the Justice Department.
In an April 11 statement, the Justice Department said CVS will conform its web content about COVID-19 vaccines to the Web Content Accessibility Guidelines, a set of voluntary industry guidelines for making website information accessible to those with disabilities.
The Justice Department said it found the company's vaccine registration portal was not accessible to people who use screen reader softwares or have trouble using a mouse.”
UK launches world-first ‘subscription’ model for antibiotic supply “The UK is set to become the first country in the world to pay drug companies a fixed fee for supplying antibiotics in an effort to tackle the growing global crisis over resistance to the drugs. The aim is to give companies a better incentive to develop new antibiotics, which would be held back to treat patients who really need them, while restraining overprescribing that leads microbes to develop drug resistance…
Under the deal being struck by the NHS with Pfizer of the US and Shionogi of Japan, the drug companies will be paid a fixed fee of £10mn a year. The current reimbursement system based on sales volume often fails to provide sufficient revenue to justify research and development spending.
The contract value was set at a level that would give international companies an incentive to invest in antibiotic research and development, if other countries pay proportionate sums scaled to their gross domestic product.”
About the public’s health
One HPV vaccine dose prevents cervical cancer - WHO “A single dose of human papillomavirus (HPV) vaccine is enough to protect against cervical cancer, a World Health Organization group of experts has said.
At the moment, two- or three-dose regimens are recommended, but the WHO's Strategic Advisory Group of Experts on Immunization said the evidence showed that one dose was as effective.”
Weekly U.S. Influenza Surveillance Report Some highlights from the CDC report:
—”The number of hospital admissions reported to HHS Protect has increased each week for the past nine weeks.
—The cumulative hospitalization rate in the FluSurv-NET system is higher than the rate for the entire 2020-2021 season, but lower than the rate seen at this time during the four seasons preceding the COVID-19 pandemic.
—Two influenza-associated pediatric deaths were reported this week. There have been 16 pediatric deaths reported this season.
—CDC estimates that, so far this season, there have been at least 3.8 million flu illnesses, 38,000 hospitalizations, and 2,300 deaths from flu.”
Black Americans’ Views of and Engagement With Science “Relatively few Black adults believe that Black people have reached the highest levels of success as scientists (36%) or engineers (43%); a 55% majority say Black people have reached this level of success as medical doctors.
By contrast, large majorities of Black adults say Black people have reached the highest levels of success as professional athletes (84%) and musicians (80%). Six-in-ten say they have done this as lawyers and 58% say they have done this in the clergy…
Most Black adults say they have either a great deal (28%) or a fair amount (50%) of confidence in medical scientists to act in the public’s best interests. About two-in-ten (21%) say they have not too much or no confidence in medical scientists.
Black Americans’ trust in medical scientists, as well as that for scientists, fell over the past year, as it also did among the general public. Even so, Black Americans’ trust in medical scientists is greater than that for other major groups and institutions including the military, K-12 public school principals and religious leaders…
The legacy of egregious medical misconduct in the U.S. Public Health Service Syphilis Study at Tuskegee, commonly known as the Tuskegee syphilis study, continues to resonate widely among Black Americans. Three-quarters of Black Americans say they have heard a lot (49%) or a little (26%) about the federal government’s study on syphilis, which withheld treatment from Black men, leading to preventable deaths and a worsening of symptoms among those study participants.”
About healthcare IT
Expiration Date of Tender Offer for Cerner Corporation Shares Extended to May 11, 2022 The headline is the story.
About health technology
Fitbit Gets FDA Clearance for AFib Detection Feature “Fitbit has received clearance from the US Food and Drug Administrationfor its atrial fibrillation detection algorithm, Google said Monday.
The technology, which Google says will be coming soon to a range of heart-rate-enabled devices, passively assesses your heartbeat rhythm. If it comes across anything that suggests AFib, it will then alert you through the Irregular Heart Rhythm Notifications feature.
Google earned clearance for the AFib-detecting technology partly because of a 2020 Heart Study which monitored over 455,000 participants for five months. The study found that Fitbit detected and correctly identified AFib episodes 98% of the time, when compared to ECG patch monitors.”